Mobile health app for monitoring allergic rhinitis and asthma in real life in Lithuanian MASK‐air users

Abstract Background MASK‐air® is an app whose aim is to reduce the global burden of allergic rhinitis (AR) and asthma. A transfer of innovative practices was performed to disseminate and implement MASK‐air® in European regions. The aim of the study was to examine the implementation of the MASK‐air® app in Lithuanian adults in order to investigate (i) the rate of acceptance in this population, (ii) the duration of app use and (iii) the evaluation of the app after its use. Methods In a longitudinal study, Lithuanian adults with AR and/or asthma were recruited by allergists. They were informed about how to use MASK‐air® and were followed closely. They were reviewed after one to 3 months to evaluate satisfaction and were asked to continue using the app. Results Among the 149 patients recruited (37.2 ± 10.4 years), 52.4% had rhinitis alone, 42.9% had rhinitis, asthma and/or conjunctivitis multimorbidity, and 2.7% isolated asthma. According to the MASK‐air® baseline questionnaire, 88.3% of patients considered that their symptoms were troublesome. Data were available for 102 (68.4%) patients. The duration of app usage in patients ranged from 1 to 680 days (median, 25–75 percentile: 54, 23.2–151 days). Forty‐two (41.1% of patients who were reviewed) patients agreed to share their opinion on MASK‐air®. Most users of the app were satisfied, from 46.5% thinking their allergy was treated more successfully to 90.4% recommending this app to other allergy sufferers. Discussion When recommended by physicians, MASK‐air® was used for a longer period of time.

isolated asthma. According to the MASK-air ® baseline questionnaire, 88.3% of patients considered that their symptoms were troublesome. Data were available for 102 (68.4%) patients. The duration of app usage in patients ranged from 1 to 680 days (median, 25-75 percentile: 54, 23.2-151 days). Forty-two (41.1% of patients who were reviewed) patients agreed to share their opinion on MASK-air ® .
Most users of the app were satisfied, from 46.5% thinking their allergy was treated more successfully to 90.4% recommending this app to other allergy sufferers. The digital transformation of health and care will benefit people, healthcare systems and the economy. The concept of digital health includes advanced medical technologies, disruptive innovations and digital communication tools, all aiming to provide the best practice care. 2 One of the three priorities of Directorate-General (DG) Santé (EU) concerning the digital transformation of health and care targets the empowerment of citizens. In this regard, digital tools can be used for user feedback and person-centred care (https://ec.europa.eu/ digital-single-market/en/news/transformation-health-and-care-digital-single-market-gaining-more-support). Such tools include, among others, mobile health apps, which can be a valuable source of realworld data.
MASK-air ® (Mobile Airways Sentinel networK), an app of the Phase 3 Allergic Rhinitis and its Impact on Asthma (ARIA) initiative, 3,4 aims to reduce the global burden of allergic rhinitis (AR) and asthma multimorbidity, giving the patient and the healthcare professional simple tools to better prevent and manage respiratory allergic diseases. MASK-air ®4 is an Information and Communications Technology system centred around the patient. [4][5][6][7] It is operational in 27 countries and 20 languages and is freely available on Android and iOS. It includes a daily monitoring questionnaire in which patients are requested to quantify the impact of AR symptoms and to provide information on the medication used. [8][9][10] However, one of its major problems is the low adherence of users: around half of the patients use the MASK-air ® app only once. 7 It is possible that adherence may improve when apps are proposed by physicians.
A transfer of innovative practices (TWINNING) 11 was performed with the aims of (i) transferring and implementing MASK-air ® in 14 different European countries (including Lithuania) 5,6 and (ii) administering the app by physicians. The "organisation transferring the innovative practice" (originator organisation) had the experience and know-how developed in rhinitis and asthma information technology solutions. The "organisation adopting the innovative practice" (receiving/adopter organisation) received the innovative practice and implemented it in its territory.
The aim of the present study was to examine the applicability of MASK-air ® in Lithuania through the TWINNING protocol, 11 assessing the duration of use of the app and including a questionnaire on patient satisfaction obtained by the physician.

| Design of the study
In this study, we assessed Lithuanian patients who were taught by their physicians how to use MASK-air®. We considered (i) their clinical and demographic features, (ii) their frequency of use of the MASK-air® app and (iii) their opinion (in a follow-up visit) of the app.

| Users and settings
Over a period of 24 months, 18-60 year-old AR and asthma patients who agreed to participate in an anonymised observational study were included in this analysis. There were no exclusion criteria. Alder, hazel, olive/ash, birch pollen, other tree pollen, grass pollen, parietaria pollen, cypress pollen, ragweed pollen, and other inhalant allergens (Inmunotek, SL,.Spain). For the patients who were using oral H 1 -antihistamines, the immunoblot panel of serum-specific IgE of inhalant allergens was performed (Euroline, Euroimmun). 13 To confirm the diagnosis in patients with asthma, spirometry with bronchodilator or the methacholine challenge test were performed according to the GINA guidelines.
The included patients were trained to use the MASK-air ® app in the clinic. An allergist, a trained student, or a resident in allergology showed each patient the MASK-air app, teaching him/her how to add data. On the same day, the patient filled in and completed the first personal evaluation of AR and asthma symptoms, and the doctor answered any practical questions. MASK-air ® collects information on patients' baseline characteristics, usual rhinitis and asthma symptoms as well as disease type (intermittent/persistent). In addition, MASK-air® comprises a daily monitoring questionnaire assessing (i) how rhinitis and asthma symptoms impact users' lives each day and (ii) type(s) of treatment used. 7,9,14

| Ethics
The MASK-air ® app is a CE1 device. 15 MASK-air ® is in line with the General Data Protection Regulation (GDPR) EU Directive 95/46/ EC. 16 The data are anonymised, including the data related to geolocalisation, using k-anonymity. 17 The overall international study was approved by the Ethics Committee of the Bohn-Cologne, and the

Lithuanian arm by the Ethics Committee of Vilnius City Clinical
Hospital n°IS-515/21(2.25). Users agreed to having their data analysed (terms of use). 11

| Follow-up of the patients
The patients were reassessed 1-3 months after starting the app, according to the routine follow-up of patients.

| Baseline characteristics of the patients
In the first outpatient visit, baseline asthma and rhinitis symptoms (including rhinorrhoea, sneezing, nasal congestion, nasal itching and ocular symptoms) were assessed using the MASK-air ® app. 10,14 That same day, we assessed the ARIA severity score which was calculated using the four questions regarding impact on sleep, daily activities, work/school attendance and bothersome symptoms. Each of these four items were ascribed a score of 1 ("Yes") or 0 ("No"). The total ARIA score ranged from 0 (no impairment) to 4 (severe impairment).
Patients also filled in the Control of Allergic Rhinitis and Asthma

Test (CARAT) questionnaire. Control of Allergic Rhinitis and Asthma
Test is a Patient-Reported Outcome that assesses the level of control of both asthma and AR in the past 4 weeks using a single tool. 18  Greece, CARAT and MASK-air ® were found to provide complementary information on AR symptom control, possibly mirroring differences in the time periods assessed by these two tools. 19

| Duration of usage
The duration of MASK-air® usage was assessed by determining the number of days of reporting, as estimated in previous studies. 20 2.5.3 | Patients' and physicians' rating of the app One to three months after starting the MASK-air ® app, the patients were asked eight questions regarding their satisfaction. Five replies were available for each question (ranging from strong disagreement to strong agreement) ( Table 1).

| Size of the study
In this pilot study, all registered users were included to obtain the best possible estimates for the specified time window.

| Analysis of the data and statistical methods
When responding to the MASK-air ® daily monitoring questionnaire, it is not possible to skip any of the questions, and data are saved to the dataset only after the final answer. This precludes any missing data. Categorical variables were described using absolute and relative frequencies, and tested using the chi-square test. Except for demographic data, a non-Gaussian distribution was found for continuous variables, and therefore medians (and percentiles) and

| Symptoms
The most common symptoms in patients with AR alone were rhinorrhoea (76.7%), sneezing (71.8%) and blocked nose (65.4%). Patients with AR and asthma most often complained of blocked nose and sneezing (85.5%), nasal itching and rhinorrhoea (67.3%). Individuals with AR and AC complained mostly of a stuffy nose and sneezing (62.5% each) (Figure 1).
Using the Bonferroni's correction, shortness of breath (p < 0.001), wheezing (p < 0.001) and chest tightness during exercise (p < 0.001) were more severe in the group of patients with multimorbid rhinitis, asthma and conjunctivitis than in those with a single disease. Comparing the severity of symptoms by gender, women had more severe symptoms of blocked nose (p = 0.003), more frequent nasal itching (p = 0.002) and greater fatigue during daily work (p < 0.001) ( Table 3 online and Figure 1). There were no significant differences in the frequency of symptoms between patients who were sensitive to one or more allergens.

| Impact of allergic diseases
According to the MASK-air ® baseline questionnaire, the vast ma- found when comparing the subjective assessment of symptoms by gender ( Figure 2). There were significant but weak-to-moderate correlations between all four outcome measures (Table 4 online).  the statements indicating that they like to use the app and that it helps to treat allergies more successfully (55.81% and 46.51%) (Figure 4).

| Rating of the app by patients
Younger patients were more likely to find the app user-friendly and to recommend it to another person with allergies (p = 0.027), but older users were more satisfied with the design of the app (p = 0.042). Comparing the responses by gender, women rated the app more favourably in all aspects. They significantly more often thought that the app was user-friendly and that the information contained was understandable (100% women vs. 80% men, p = 0.043). Compared by disease, patients in the sole AR group were more likely to find the app user-friendly (p = 0.012).

| DISCUSSION
In this study, we assessed patients with sole or multimorbid AR recruited by physicians. These patients were taught how to use the MASK-air ® app. The recruited users appear to be similar to European MASK-air ® users overall regarding their demographic and clinical characteristics, but they display substantially higher adherence to the app. Overall, this suggests that adherence to mobile apps may be higher when the latter are promoted by physicians and when the users are taught how to use them. Of note, this study also found that patients In the present study, we found that most patients had either AR alone (52.4%) or both AR and asthma (36.9%). In the first set of analyses, we assessed AR symptoms and impact at baseline. We then compared them with a recent MASK-air ® paper in which 9037 European users from 17 countries were investigated. 10 In the former study, users had slightly fewer symptoms, particularly outside the predicted pollen season, than in the current study, and the impact was also less important. Thus, patients included in this study may have more severe presentations than overall MASK-air ® users, possibly because they were recruited from an allergy clinic. However, in both studies, bothersome symptoms were found in 68% (outside the pollen season), 76% (during the pollen season) and 88% (current study) of cases (Table 5 online).

T A B L E 3 Sensitisation profile of patients
Achieving sufficient mHealth App engagement and user retention rates is a difficult task. 22   (mean: 17.83 days/user). In the present study, there were 10,928 days for 102 patients (mean: 107.14 days/user). Although it is difficult to compare two sets of data, users reporting MASK-air ® data use the same app similarly, and the very large difference suggests that when an app is proposed by physicians (who train their patients to use it), the patients report their use for a longer period of time.
This does not apply to all users, but only one patient included in this study reported a single day of MASK-air ® use. The low retention rate of mobile apps is not restricted to MASK-air ® . Numerous factors have been identified to potentially influence engagement, and it is important to consider these in order to best overcome them. 23,24 Engagement strategies should consider usability of technology, motivating factors and the need for personal contact. In the present study, personal professional contact with physicians and a short training session on the use of the app are likely to lead to a higher retention rate (Table 6).

| CONCLUSIONS
This study suggests that when mHealth apps are proposed by physicians, users report data for a longer period of time.